The Consequences of Overdiagnosis and Overtreatment of Lyme Disease: An Observational Study

Reid, M. Carrington; Schoen, Robert T.; Evans, John; Rosenberg, J C; Horwitz, RalphI.

doi:10.7326/0003-4819-128-5-199803010-00003

Cited by 147 publications

(108 citation statements)

References 18 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…Preliminary studies in our laboratory have demonstrated considerable variation in Lyme WB results when strips are visually read by different laboratory technologists (M. Binnicker, unpublished data). This variation in WB results may contribute to inaccurate diagnoses, resulting in various consequences to patients, as described in past studies (4,13,14,17). Therefore, an important need of clinical laboratories is to enhance the objectivity and consistency of Lyme WB interpretation.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of Two Commercial Systems for Automated Processing, Reading, and Interpretation of Lyme Borreliosis Western Blots

Binnicker¹,

Jespersen²,

Harring³

et al. 2008

J Clin Microbiol

View full text Add to dashboard Cite

The diagnosis of Lyme borreliosis (LB) is commonly made by serologic testing with Western blot (WB) analysis serving as an important supplemental assay. Although specific, the interpretation of WBs for diagnosis of LB (i.e., Lyme WBs) is subjective, with considerable variability in results. In addition, the processing, reading, and interpretation of Lyme WBs are laborious and time-consuming procedures. With the need for rapid processing and more objective interpretation of Lyme WBs, we evaluated the performances of two automated interpretive systems, TrinBlot/BLOTrix (Trinity Biotech, Carlsbad, CA) and BeeBlot/ViraScan (Viramed Biotech AG, Munich, Germany), using 518 serum specimens submitted to our laboratory for Lyme WB analysis. (7), confirming that the disease continues to represent a significant public health threat. The clinical manifestations of early localized disease range from nonspecific sequelae, including malaise, myalgia, and lymphadenopathy, to more characteristic findings, such as erythema migrans (EM). In the absence of appropriate therapy, disease progression may lead to significant complications, including rheumatologic, neurologic, or cardiac manifestations (15, 16).The diagnosis of Lyme borreliosis (LB) can be made clinically when patients from regions where the disease is endemic present with EM (5, 8, 18). However, in patients without EM but with objective clinical findings suggestive of disseminated LB, serologic testing is an important diagnostic approach. Appropriate serologic testing should follow the two-tier algorithm recommended by the CDC (6), consisting of initial testing with a sensitive screening assay (e.g., enzyme immunoassay) with positive or equivocal specimens to be tested by Western blot (WB) analysis. Current CDC criteria for WB interpretation recommend that Ն2 bands on the immunoglobulin M (IgM) WB or Ն5 bands on the IgG WB be present for the immunoblot to be considered positive (6, 9). Although WB is considered to be highly specific, current testing protocols in most clinical laboratories rely on visual reading and interpretation of WB strips. These procedures require the laboratory technologist to visually compare band intensities on the patient strip to those of a weakly reactive control. This approach is laborintensive, time-consuming, and subjective, allowing for potential intra-and interlaboratory variation in WB reading and interpretation. Previous studies analyzing the performance of LB serologic tests among testing laboratories have demonstrated significant variation in results, even for more objective methods, such as enzyme immunoassay (2, 3, 10). Therefore, given the inherent subjectivity in reading and interpreting WBs for diagnosis of LB (i.e., Lyme WBs), one would expect to observe significant variation in WB results, with potentially adverse effects on the laboratory diagnosis of Lyme disease and subsequent patient management decisions. Due to the need for more objective and consistent interpretation of Lyme WBs, we undertook a study to evaluate and comp...

show abstract

Section: Discussionmentioning

confidence: 99%

Evaluation of Two Commercial Systems for Automated Processing, Reading, and Interpretation of Lyme Borreliosis Western Blots

Binnicker¹,

Jespersen²,

Harring³

et al. 2008

J Clin Microbiol

View full text Add to dashboard Cite

show abstract

“…In general, only about one quarter to one third of the patients evaluated were thought to have Lyme disease; in comparison, between 50 to 60% of the patients had no present or past evidence of Lyme disease. A large portion of patients presented with fatigue, myalgias, arthralgias, sleep disturbances, memory complaints and/or depression, and many fulfilled criteria for chronic fatigue syndrome or fibromyalgia [5][6][7][8][9][10]. Common and related problems contributing to the over diagnosis of Lyme disease included the use of serological testing in clinical situations in which the pre-test probability of Lyme disease was low, misinterpretation of test results, and use of non-validated methods and criteria for interpretation of laboratory results.…”

Section: Chronic Lyme Diseasementioning

confidence: 99%

Chronic Lyme Disease: A Review

Marques

2008

Infectious Disease Clinics of North America

175

123

View full text Add to dashboard Cite

“…In contrast with the findings of evidence-based medicine, some people believe that the tests for Lyme disease are often inaccurately negative, and that antibiotic therapy is necessary for months or years to suppress the symptoms of this often incurable illness. A number of investigators at academic medical centers have reported series of patients referred for chronic Lyme disease in which the majority of patients had pain or fatigue syndromes with little or no evidence of past or present B. burgdorferi infection (85)(86)(87). Prolonged antibiotic therapy may be harmful.…”

Section: Figurementioning

confidence: 99%

The emergence of Lyme disease

Steere

Coburn²,

Glickstein³

2004

J. Clin. Invest.

636

388

View full text Add to dashboard Cite

The Consequences of Overdiagnosis and Overtreatment of Lyme Disease: An Observational Study

Abstract: Overdiagnosis and overtreatment of Lyme disease are associated with inappropriate use of health services, avoidable treatment-related illness, and substantial disability and distress.

Cited by 147 publications

References 18 publications

Evaluation of Two Commercial Systems for Automated Processing, Reading, and Interpretation of Lyme Borreliosis Western Blots

Evaluation of Two Commercial Systems for Automated Processing, Reading, and Interpretation of Lyme Borreliosis Western Blots

Chronic Lyme Disease: A Review

The emergence of Lyme disease

Contact Info

Product

Resources

About